Costco recalls Kirkland cold and flu medicine: again

For the second time in less than a month, Costco is pulling its own-brand cold and flu medicine from shelves.

The retailer is pulling its Kirkland Signature Severe Cold & Flu Plus Congestion from shelves due to the potential of foreign material contamination, the Issaquah, Wash., warehouse retailer announced on its website over the weekend.

The medicine’s manufacturer, LNK International Inc., initiated the recall out of “an abundance of caution.”The over-the-counter medicine in question was sold between Oct. 30 and Nov. 30, 2024, and is associated with item number #1729556 and specific lot code P140082. The product was sold at Costco locations in the Midwest and Southeast.

So far, no illnesses associated with the medication have been reported.

Last month, over 8,600 boxes of Kirkland Severe Cold & Flu Plus Congestion Day and Night packs were recalled by the Food & Drug Administration (FDA) due to an ingredient, oral phenylephrine, that was deemed not effective as a nasal decongestant.In November, the FDA proposed banning oral phenylephrine as an over-the-counter nasal decongestant.“It’s the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

The agency said it conducted a comprehensive review of available data on the safety and efficacy of oral phenylephrine, including the historical data that were used to support the determination made 30 years ago that oral phenylephrine was effective as a nasal decongestant, as well as newer clinical data.